FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AFX Endovascular AAA System
DI: 00818009011237
·
Model: A22-22/C75
·
Endologix LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AFX Endovascular AAA System
- Primary DI
- 00818009011237
- Version / Model
- A22-22/C75
- Company Name
- Endologix LLC
- Labeler DUNS
- 858560477
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 12
- Public Version Date
- 2026-03-30
- Public Version Status
- Update
- Public Device Record Key
- 49d8d3c6-07b1-4e95-8756-4a6bd4f9e25e
- Distribution End Date
- 2020-10-28
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46777 | Aortoiliac endovascular stent-graft | A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818009011237 | GS1 |
Customer Contacts
- Phone
- (949) 595-7200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040002 | 031 |
| P040002 | 032 |
| P040002 | 033 |
| P040002 | 034 |
| P040002 | 035 |
| P040002 | 036 |
| P040002 | 037 |
| P040002 | 038 |
| P040002 | 039 |
| P040002 | 040 |
| P040002 | 041 |
| P040002 | 042 |
| P040002 | 043 |
| P040002 | 044 |
| P040002 | 045 |
| P040002 | 046 |
| P040002 | 047 |
| P040002 | 048 |
| P040002 | 049 |
| P040002 | 050 |
| P040002 | 051 |
| P040002 | 052 |
| P040002 | 054 |
| P040002 | 056 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 22 mm, Distal Diameter | ||
| Device Size Text, specify | 75 mm, Covered Extension Length | ||
| Device Size Text, specify | 0 mm, Uncovered Extension Length | ||
| Device Size Text, specify | 22 mm, Proximal Diameter |